Cough and cold meds withdrawal is working: study

NEW YORK (Reuters Health) - The number of young children going to the emergency room after taking too much cough and cold medicine was cut in half after drug companies took medications for their age group off the market, according to a new study.

Doctors say the research, published today in the journal Pediatrics, shows that taking the medications off the shelves did what it was intended to do - but that there is still more that both drug makers and parents can do to protect kids from ending up in the emergency room.

"Overall, I think this is really good," said Dr. Daniel Budnitz, the lead author on the study from the Centers for Disease Control and Prevention. But, "people might say, 'Wait a minute, these drugs can't be marketed anymore. It should be zero (emergency room) visits.'"

In late 2007, manufacturers of cough and cold medicines came together and decided that they would stop selling these medications for use in kids less than two years old. Since then, the withdrawal has been updated to include cold and cough medicines for all kids less than 4 years old. The U.S. Food and Drug Administration also recommended in January 2008 that parents avoid the use of these products to treat children less than 2 "because serious and potentially life-threatening side effects can occur."

Before the initial withdrawal, "there were no solid data to show that cough and cold medications actually work for kids, and they do cause side effects sometimes," said Dr. Eric Lavonas, the associate director of the Rocky Mountain Poison and Drug Center in Denver, who was not involved with the study.

The antihistamines and decongestants in some of these medicines can especially be a problem when kids take more than the recommended dose, said Dr. Michael Rieder, who studies drugs and drug effects in kids at the University of Western Ontario in Canada and was also not involved with the current research.

To examine the impact of taking these medicines off the market, Budnitz and his colleagues looked at the number of kids going to emergency rooms for problems related to cough and cold medications before and after they were pulled. Using a sample of about 60 hospitals in the United States, the authors estimated the number of these cases nationwide pre- and post-withdrawal.

In the 14 months before the original withdrawal was made, about 2,800 kids younger than 2 years old went to the emergency room after they had taken cough and cold medicines. In the 14 months after, that number dropped to approximately 1,250 kids. For older kids, the number of emergency room visits didn't change significantly.

"What this study shows is exactly what you expect," Lavonas said. "People are no longer buying these medications for use by small children, and as a result small children are not getting into them by accident."

Kids who show up in the emergency room for problems related to these medications often take too much when a parent isn't looking, but sometimes it's the parents themselves that give the kid too much by mistake, Budnitz said. The good news is, there are ways for the companies that make the medications and for parents to cut down on both of those problems.

Cough and cold medicines made for older kids and for adults need to be designed so that it's much harder for kids to get into them and accidentally take a dangerous amount, Lavonas said. In addition, instructions on the medicine bottles should be more obvious about the appropriate dose for kids who are old enough to take them, he added.

For parents, Budnitz said, the important thing is to not give cough and cold medications to kids younger than 4, and to make sure that all of the family's medicines are kept "up and away and out of sight."

When kids are sick, parents can give appropriate doses of Tylenol and make sure their kid is comfortable and drinking plenty of fluids, Rieder said.

If your kid does get into a cough and cold medication bottle and take too much, you shouldn't necessarily run to the nearest emergency room, Lavonas said.

"If your child is not critically ill right in front of you, your very first call should be to your local poison control center," he said.

Most of the kids in this study probably did not need to go to the emergency room, he said - and a poison control center can tell parents what to look for and when going to the hospital is necessary, he said.

Doctors are hopeful that going forward fewer and fewer children might be showing up at the emergency room after taking too much cough and cold medication - provided that both companies and parents do their part.

The withdrawal "has been successful in dramatically reducing events in young children," Lavonas said. "Perfect success would be no child ever harmed."